CEVA and Bragi Partner on Hearable Devices
Target devices include headsets, hearing aids, True Wireless Stereo (TWS) earbuds, and a host of other smart audio devices for the consumer and the smart home.
Category: Personal Sound Amplification
Personal Sound Amplification
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Personal Sound Amplification
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Nuheara Launches IQbuds2 Max at CES 2020
Nuheara, the smart-hearing company, announced the launch of IQbuds2 MAX. Built on...
Personal Sound Amplification
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FDA Issues Letter to “OTC Hearing Aid” Manufacturers
A letter by the FDA's William Maisel cautions that hearing devices cannot use “OTC hearing aids” in their marketing since the FDA definition of this hearing aid class—which would probably include severity of loss and other important safety, quality, and labeling requirements—has not yet been established.
Mead Killion Adds to Humes’ Comments Regarding PSAP/OTC Findings
Mead Killion, PhD, provides his perspective on the audiograms used in two studies that look at the suitability of personal sound amplification products (PSAPS) for people with hearing loss in various delivery models.
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IntriCon Reports Sales Increase of 28.5% in 2018
IntriCon, a major value-based hearing device and PSAP developer and manufacturer, announced revenues of $116.5 million in 2018, up 28.5% from $90.6 million in 2017. The company sees continued growth ahead, as its President and CEO Mark Gorder predicts FDA guidance on over-the-counter hearing devices by the end of this year, with final OTC regulations by the first half of 2020.
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Exploring Community Health Worker (CHW) Models for Delivering Audiology Services
The purpose of this study was to understand perceptions of audiologists with regards to a novel service delivery model that involves the use of community healthcare workers (CHWs) in audiology.
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Evaluating Select Personal Sound Amplifiers and a Consumer-Decision Model for OTC Amplification
OTC hearing devices are coming, but how should they function and for whom should they be recommended? Drs Ron Leavitt, Ruth Bentler, and Carol Flexer present six case studies showing that people with true moderate hearing loss may not be well served by what has been characterized as a “consumer-decides” model of care.
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iHEAR Medical Announces OTC Product Launch in Stores; Appoints John Luna CEO
iHEAR will launch the TReO, what the company says is the “first prescription-quality hearing amplifier for OTC markets,” and the iHearTest kit, a FDA-cleared home hearing screener, in 500 drugstores in June 2018.
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InnerScope Hearing Technologies Announces New E-Commerce Store
InnerScope continues to expand infrastructure and growth capabilities within its new e-commerce platform, according to the company.
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InterScope Hearing Technologies and Blue-Gear Enter Into Agreement
The agreement expands and broadens InnerScope Hearing Technologies’ presence in the new emerging PSAP’s and hearables markets.
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Staff Standpoint: OTC Debate Moves on to FDA, FTC…and States?
The debate now moves from “if” an OTC class of hearing devices should exist to “what” that OTC class will look like.
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Some PSAPs Show Improvements in Hearing Similar to Hearing Aids, Says JAMA Study
Three of the PSAPs were associated with improvements in speech understanding that were similar to results obtained with the hearing aid; one demonstrated little improvement; and speech understanding was worse with one PSAP.
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Consumer Technology Association Releases New Logo for OTC Hearing Devices
The new logo and standard will help consumers in the future, distinguish high-quality hearing enhancement devices for mild to moderate hearing loss from what the CTA says are “ineffective” personal amplifiers commonly found today.
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Some Turbulent Seas Ahead…
This month’s cover is meant to depict the turmoil that our industry finds itself in, as disruptive technology threatens to change some long-standing rules about hearing aid distribution and over-the-counter (OTC) hearing aids move a step closer to reality.
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OTC Hearing Aid Bill Moves Out of Committee; CTA Praises Legislation
Gary Shapiro of the Consumer Technology Association (CTA) praised the House Energy and Commerce Committee for approving the Medical Device User Fee Amendments (MDUFA) user fee package that included the over-the-counter (OTC) hearing aid provision.
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FTC to Host April 18 Workshop on Hearing Care
The “Now Hear This” workshop will start at 9:00 am, with Acting Chairman Ohlhausen delivering opening remarks. The event will examine hearing care issues, especially as they relate to competition, innovation, and consumer protection and will be webcast live from the FTC’s web page.
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Elite 2017 Business Summit Elevates Independents in Era of Disruptive Change
This year’s Summit theme was “Elevate Your Independence,” focusing on how independent hearing care professionals can succeed in an era of disruptive technology, distribution, and what may ultimately be a new regulatory environment. Included in the Summit’s General Session was a historical perspective on the current over-the-counter device proposals, as well as a review of a recent pilot study that supports professionally dispensed hearing aids over OTC.
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HIA Recommends OTC Hearing Devices Be Restricted to Mild Losses; Retain Consumer Safety and Efficacy Assurances
The Hearing Industries Association has recommended that, if the FDA creates a new over-the-counter (OTC) category for hearing devices, these products be confined to mild hearing losses and comply with the same safety and efficacy standards required for air-conduction hearing aids. Further, if the OTC category is established, HIA recommends that FDA review and finalize its guidance for PSAPs so these devices cannot be marketed to address hearing loss.
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